High resistance implanted bronchial isolation devices and methods

ABSTRACT

Disclosed are methods and devices for regulating fluid flow to and from a region of a patient&#39;s lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. Pursuant to an exemplary procedure, an identified region of the lung is targeted for treatment. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region. An exemplary flow control device is configured to block fluid flow in the inspiratory direction and the expiratory direction at normal breathing pressures and allow fluid flow in the expiratory direction at higher than normal breathing pressures.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/714,868 (Attorney Docket No. 20920-776.201), filed Sep. 25,2017, which claims the benefit of U.S. Provisional No. 62/404,688(Attorney Docket No. 20920-776.101), filed Oct. 5, 2016, the fulldisclosures of which are incorporated herein by reference.

FIELD OF THE INVENTION

This disclosure relates generally to methods and devices for use inperforming pulmonary procedures and, more particularly, to proceduresfor treating lung diseases.

BACKGROUND OF THE INVENTION

Pulmonary diseases, such as chronic obstructive pulmonary disease,(COPD), reduce the ability of one or both lungs to fully expel airduring the exhalation phase of the breathing cycle. Such diseases areaccompanied by chronic or recurrent obstruction to air flow within thelung. Because of the increase in environmental pollutants, cigarettesmoking, and other noxious exposures, the incidence of COPD hasincreased dramatically in the last few decades and now ranks as a majorcause of activity-restricting or bed-confining disability in the UnitedStates. COPD can include such disorders as chronic bronchitis,bronchiectasis, asthma, and emphysema.

It is known that emphysema and other pulmonary diseases reduce theability of one or both lungs to fully expel air during the exhalationphase of the breathing cycle. One of the effects of such diseases isthat the diseased lung tissue is less elastic than healthy lung tissue,which is one factor that prevents full exhalation of air. Duringbreathing, the diseased portion of the lung does not fully recoil due tothe diseased (e.g., emphysematic) lung tissue being less elastic thanhealthy tissue.

Consequently, the diseased lung tissue exerts a relatively low drivingforce, which results in the diseased lung expelling less air volume thana healthy lung. The reduced air volume exerts less force on the airway,which allows the airway to close before all air has been expelled,another factor that prevents full exhalation.

The problem is further compounded by the diseased, less elastic tissuethat surrounds the very narrow airways that lead to the alveoli, whichare the air sacs where oxygen-carbon dioxide exchange occurs. Thediseased tissue has less tone than healthy tissue and is typicallyunable to maintain the narrow airways open until the end of theexhalation cycle. This traps air in the lungs and exacerbates thealready-inefficient breathing cycle. The trapped air causes the tissueto become hyper-expanded and no longer able to effect efficientoxygen-carbon dioxide exchange.

In addition, hyper-expanded, diseased lung tissue occupies more of thepleural space than healthy lung tissue. In most cases, a portion of thelung is diseased while the remaining part is relatively healthy and,therefore, still able to efficiently carry out oxygen exchange. Bytaking up more of the pleural space, the hyper-expanded lung tissuereduces the amount of space available to accommodate the healthy,functioning lung tissue. As a result, the hyper-expanded lung tissuecauses inefficient breathing due to its own reduced functionality andbecause it adversely affects the functionality of adjacent healthytissue.

Some recent treatments include the use of devices that isolate adiseased region of the lung in order to reduce the volume of thediseased region, such as by collapsing the diseased lung region.According to such treatments, one or more flow control devices areimplanted in airways feeding a diseased region of the lung to regulatefluid flow to the diseased lung region in order to fluidly isolate theregion of the lung. These implanted flow control devices can be, forexample, one-way valves that allow flow in the exhalation directiononly, occluders or plugs that prevent flow in either direction, ortwo-way valves that control flow in both directions. However, suchdevices are still in the development stages.

Thus, there is much need for improvement in the design and functionalityof such flow control devices.

SUMMARY OF THE INVENTION

Disclosed are methods and devices for regulating fluid flow to and froma region of a patient's lung, such as to achieve a desired fluid flowdynamic to a lung region during respiration and/or to induce collapse inone or more lung regions. In one aspect, a flow control device suitablefor implanting in a bronchial passageway is described. The flow controldevice comprises a valve element comprising a first lip and a secondlip, wherein the first and second lips are configured to transition thevalve element between a closed configuration that blocks air flow in theinspiratory direction and an open configuration that permits air flow inan expiratory direction. The first and second lips are configured to bein the closed configuration when exposed to no air flow, air flow in theinspiratory direction, and air flow in the expiratory direction atnormal breathing pressures. The first and second lips may beadditionally configured to be in the open configuration when exposed toair flow in the expiratory direction in the range of 12-24 inches H₂O.The first and second lips may be configured to be in the openconfiguration when exposed to air flow in the expiratory direction inthe range of 121-160 inches H₂O.

In an embodiment, the first and second lips are configured to beparallel with respect to one another in the closed configuration. Thevalve element may further comprise two opposed inclined flaps leading tothe first and second lips, wherein the two inclined flaps are orientedat an angle with respect to one another. The angle may be in the rangeof 70 to 110 degrees. The first and second lips may be configured to beparallel with a longitudinal axis of the valve while in the closedconfiguration. The two inclined flaps may be oriented at an anglerelative to a longitudinal axis of the valve while in the closedconfiguration. In an embodiment, the flow control device may furthercomprise a frame configured to retain the flow control device within thebronchial passageway and a seal coupled to the frame. In an embodiment,the length of the parallel and contacted parallel lips extendinglongitudinally beyond the two inclined flaps is at least 30% as long asa length of the inclined flaps. The seal may be configured to sealagainst internal walls of the bronchial passageway.

In one aspect, the flow control device comprises a valve comprisingcoaptation regions comprising two opposed inclined flaps and twoparallel lips connected to the inclined flaps, wherein the coaptationregions are configured to transition the valve element between a closedconfiguration that blocks air flow in the inspiratory direction and anopen configuration that permits air flow in an expiratory direction. Thecoaptation regions are configured to be in the closed configuration whenexposed to no air flow, air flow in the inspiratory direction, and airflow in the expiratory direction at normal breathing pressures, andwherein the coaptation regions are configured to be in the openconfiguration when exposed to air flow in the expiratory direction atcoughing pressures.

This and other aspects of the present disclosure are described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Present embodiments have other advantages and features which will bemore readily apparent from the following detailed description and theappended claims, when taken in conjunction with the accompanyingdrawings, in which:

FIG. 1 shows an anterior view of a pair of human lungs and a bronchialtree with a flow control device implanted in a bronchial passageway tobronchially isolate a region of the lung.

FIG. 2 illustrates an anterior view of a pair of human lungs and abronchial tree

FIG. 3A illustrates a lateral view of the right lung.

FIG. 3B illustrates a lateral view of the left lung.

FIG. 4 illustrates an anterior view of the trachea and a portion of thebronchial tree.

FIG. 5A shows a perspective view of an exemplary flow control devicethat can be implanted in a body passageway.

FIG. 5B shows a perspective, cross-sectional view of the flow controldevice of FIG. 5A.

FIG. 6A shows a side view of the flow control device of FIG. 5A.

FIG. 6B shows a cross-sectional, side view of the flow control device ofFIG. 5A.

FIG. 7 shows another embodiment of a flow control device.

FIG. 8A shows a side, cross-sectional view of a duckbill valve in aclosed state.

FIG. 8B shows a side, cross-sectional view of a duckbill valve in anopen state.

FIG. 9 shows a side, cross-sectional view of a duckbill valve with acracking pressure above normal breathing pressures.

FIGS. 10A-E show an exemplary duckbill valve with a cracking pressureabove normal breathing pressures.

FIGS. 11A-E show an alternative duckbill valve with a cracking pressureabove normal breathing pressures.

FIGS. 12A-E show an embodiment of a duckbill valve with a crackingpressure above normal breathing pressures.

DETAILED DESCRIPTION OF THE INVENTION

While the invention has been disclosed with reference to certainembodiments, it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted withoutdeparting from the scope of the invention. In addition, manymodifications may be made to adapt to a particular situation or materialto the teachings of the invention without departing from its scope.

Throughout the specification and claims, the following terms take themeanings explicitly associated herein unless the context clearlydictates otherwise. The meaning of “a”, “an”, and “the” include pluralreferences. The meaning of “in” includes “in” and “on.” Referring to thedrawings, like numbers indicate like parts throughout the views.Additionally, a reference to the singular includes a reference to theplural unless otherwise stated or inconsistent with the disclosureherein.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any implementation described herein as“exemplary” is not necessarily to be construed as advantageous overother implementations.

Disclosed are methods and devices for regulating fluid flow to and froma region of a patient's lung, such as to achieve a desired fluid flowdynamic to a lung region during respiration and/or to induce collapse inone or more lung regions. Pursuant to an exemplary procedure, anidentified region of the lung (referred to herein as the “targeted lungregion”) is targeted for treatment. The targeted lung region is thenbronchially isolated to regulate airflow into and/or out of the targetedlung region through one or more bronchial passageways that feed air tothe targeted lung region.

As shown in FIG. 1, the bronchial isolation of the targeted lung regionis accomplished by implanting a flow control device 110 (sometimesreferred to as a bronchial isolation device) into a bronchial passageway115 that feeds air to a targeted lung region 120. The flow controldevice 110regulates fluid flow through the bronchial passageway 115 inwhich the flow control device 110 is implanted. The flow control device110 can regulate airflow through the bronchial passageway 115 using avalve that permits fluid flow in a first direction (e.g., the exhalationdirection) while limiting or preventing fluid flow in a second direction(e.g., the inhalation direction).

The valve includes coaptation regions nthat are moveable toward and awayfrom one another so as to define an opening through which fluid canflow. When exposed to fluid flow with sufficient pressure in the firstdirection (e.g., the exhalation direction), the coaptation regions areurged away from one another permit fluid flow through the valve. Whenexposed to fluid flow in the second direction (e.g., the inhalationdirection), the coaptation regions are urged toward one another todecrease the size of and/or completely close the opening to decreaseand/or completely prevent fluid flow through the valve. Flow through thevalve is completely prevented when the coaptation regions are completelyshut such that there is no opening for fluid to flow through the valve.

As described in detail below, the flow control device 110 can include avalve that is closed in a default state such that there is no gap oropening between the coaptation regions of the valve. The coaptationregions separate from one another to form an opening for fluid flow inthe first direction when the valve cracking pressure is exceeded. Forsuch a valve, there is a tendency for the coaptation regions, such asthe valve lips, to stick together so as to resist opening and therebyincrease the valve cracking pressure. The sticking force between thecoaptation regions can be stronger when the valve is implanted in alung, as mucous can coat the valve lips and form surface tension thatmust be overcome to separate the lips and open the valve.

Throughout this disclosure, reference is made to the term “lung region”.As used herein, the term “lung region” refers to a defined division orportion of a lung. For purposes of example, lung regions are describedherein with reference to human lungs, wherein some exemplary lungregions include lung lobes and lung segments. Thus, the term “lungregion” as used herein can refer, for example, to a lung lobe or a lungsegment. Such nomenclature conform to nomenclature for portions of thelungs that are known to those skilled in the art. However, it should beappreciated that the term “lung region” does not necessarily refer to alung lobe or a lung segment, but can refer to some other defineddivision or portion of a human or nonhuman lung.

FIG. 2 shows an anterior view of a pair of human lungs 210, 215 and abronchial tree 220 that provides a fluid pathway into and out of thelungs 210, 215 from a trachea 225, as will be known to those skilled inthe art. As used herein, the term “fluid” can refer to a gas, a liquid,or a combination of gas(es) and liquid(s). For clarity of illustration,FIG. 2 shows only a portion of the bronchial tree 220, which isdescribed in more detail below with reference to FIG. 5.

Throughout this description, certain terms are used that refer torelative directions or locations along a path defined from an entrywayinto the patient's body (e.g., the mouth or nose) to the patient'slungs. The path of airflow into the lungs generally begins at thepatient's mouth or nose, travels through the trachea into one or morebronchial passageways, and terminates at some point in the patient'slungs. For example, FIG. 2 shows a path 202 that travels through thetrachea 225 and through a bronchial passageway into a location in theright lung 210. The term “proximal direction” refers to the directionalong such a path 202 that points toward the patient's mouth or nose andaway from the patient's lungs. In other words, the proximal direction isgenerally the same as the expiration direction when the patientbreathes. The arrow 204 in FIG. 2 points in the proximal or expiratorydirection. The term “distal direction” refers to the direction alongsuch a path 202 that points toward the patient's lung and away from themouth or nose. The distal direction is generally the same as theinhalation or inspiratory direction when the patient breathes. The arrow206 in FIG. 2 points in the distal or inhalation direction.

The lungs include a right lung 210 and a left lung 215. The right lung210 includes lung regions comprised of three lobes, including a rightupper lobe 230, a right middle lobe 235, and a right lower lobe 240. Thelobes 230, 235, 240 are separated by two interlobar fissures, includinga right oblique fissure 226 and a right transverse fissure 228. Theright oblique fissure 226 separates the right lower lobe 240 from theright upper lobe230 and from the right middle lobe 235. The righttransverse fissure 228 separates the right upper lobe 230 from the rightmiddle lobe 235.

As shown in FIG. 2, the left lung 215 includes lung regions comprised oftwo lobes, including the left upper lobe 250 and the left lower lobe255. An interlobar fissure comprised of a left oblique fissure 245 ofthe left lung 215 separates the left upper lobe 250 from the left lowerlobe 255. The lobes 230, 235, 240, 250, 255 are directly supplied airvia respective lobar bronchi, as described in detail below.

FIG. 3A is a lateral view of the right lung 210. The right lung 210 issubdivided into lung regions comprised of a plurality ofbronchopulmonary segments. Each bronchopulmonary segment is directlysupplied air by a corresponding segmental tertiary bronchus, asdescribed below. The bronchopulmonary segments of the right lung 210include a right apical segment 310, a right posterior segment 320, and aright anterior segment330, all of which are disposed in the right upperlobe 230. The right lung bronchopulmonary segments further include aright lateral segment 340 and a right medial segment 350, which aredisposed in the right middle lobe 235. The right lower lobe 240 includesbronchopulmonary segments comprised of a right superior segment 360, aright medial basal segment (which cannot be seen from the lateral viewand is not shown in FIG. 3A), a right anterior basal segment 380, aright lateral basal segment 390, and a right posterior basal segment395.

FIG. 3B shows a lateral view of the left lung 215, which is subdividedinto lung regions comprised of a plurality of bronchopulmonary segments.The bronchopulmonary segments include a left apical segment 410, a leftposterior segment 420, a left anterior segment 430, a left superiorsegment440, and a left inferior segment 450, which are disposed in theleft lung upper lobe 250. The lower 15 lobe 225 of the left lung 215includes bronchopulmonary segments comprised of a left superior segment460, a left medial basal segment (which cannot be seen from the lateralview and is not shown in FIG. 3B), a left anterior basal segment 480, aleft lateral basal segment 490, and a left posterior basal segment 495.

FIG. 4 shows an anterior view of the trachea 225 and a portion of thebronchial tree 220, which includes a network of bronchial passageways,as described below. In the context of describing the lung, the terms“pathway” and “lumen” are used interchangeably herein. The trachea 225divides at a lower end into two bronchial passageways comprised ofprimary bronchi, including a right primary bronchus 510 that providesdirect air flow to the right lung 210, and a left primary bronchus 515that provides direct air flow to the left lung 215. Each primarybronchus 510, 515 divides into a next generation of bronchialpassageways comprised of a plurality of lobar bronchi. The right primarybronchus 510 divides into a right upper lobar bronchus 517, a rightmiddle lobar bronchus 520, and a right lower lobar bronchus 522. Theleft primary bronchus 515 divides into a left upper lobar bronchus 525and a left lower lobar bronchus 530. Each lobar bronchus, 517, 520, 522,525, 530 directly feeds fluid to a respective lung lobe, as indicated bythe respective names of the lobar bronchi. The lobar bronchi each divideinto yet another generation of bronchial passageways comprised ofsegmental bronchi, which provide air flow to the bronchopulmonarysegments discussed above.

As is known to those skilled in the art, a bronchial passageway definesan internal lumen through which fluid can flow to and from a lung orlung region. The diameter of the internal lumen for a specific bronchialpassageway can vary based on the bronchial passageway's location in thebronchial tree (such as whether the bronchial passageway is a lobarbronchus or a segmental bronchus) and can also vary from patient topatient. However, the internal diameter of a bronchial passageway isgenerally in the range of 3 millimeters (mm) to 10 mm, although theinternal diameter of a bronchial passageway can be outside of thisrange. For example, a bronchial passageway can have an internal diameterof well below 1 mm at locations deep within the lung.

Flow Control Device. Some of the breathing patterns that arecharacteristic of patients with severe emphysema are that the patientsare able to inhale very easily and yet exhale with great difficulty. Thedestruction of lung parenchyma in the diseased regions of the lung leadsto a loss of elastic recoil for the diseased lung region. The resultingimbalance in elastic recoil between diseased and healthier lung regionsresults in the diseased lung regions filling with air easily and firstduring inspiration. However, the diseased regions empty last and withgreat difficulty during expiration, as there is little or no elasticrecoil remaining in the diseased lung regions to assist in the expellingof air. Adding to this difficulty, the distal airways in the diseasedlung regions collapse during exhalation due to the loss of tetheringforces that hold the airways open during exhalation in normal lungregions. As pleural pressure increases at the beginning of expiration,these distal airways partially or fully collapse, thus decreasing theexhalation flow, and increasing the work and time required for thepatient to fully exhale.

To help ease the symptoms of emphysema and to improve breathingmechanics, implantation of one-way flow control devices or valvebronchial isolation devices has been employed, as described in severalprior U.S. patent applications, including “Methods and Devices for usein Performing Pulmonary Procedures”, Ser. No. 09/797,910, filed Mar. 2,2001, “Bronchial Flow Control Devices and Methods of Use”, Ser. No.10/270,792, filed Oct. 10, 2002, and “Implanted Bronchial IsolationDevices And Methods”, Ser. No. 12/885,199, filed Sep. 17, 2010 which areincorporated herein by reference.

FIGS. 5A-6B show an exemplary embodiment of a flow control device 110that generally includes a valve, a frame or anchor, and a seal memberfor sealing against a wall of a bronchial passageway. It should beappreciated that the flow control device 110 shown in FIGS. 5A-6B isexemplary and that the frame, seal member, and valve can vary instructure. The flow control device 110 has a general outer shape andcontour that permits the flow control device 110 to fit entirely or atleast partially within a body passageway, such as within a bronchialpassageway.

The valve is configured to regulate fluid flow through a bronchialpassageway in which the device 110 is implanted. The valve opens andvents fluid (such as gas or liquid, including mucous) when the pressureacross the valve due to flow in a first direction, such as theexhalation direction, exceeds the rated cracking pressure of the valve.Thus, the valve opens in response to fluid flow in the first direction.The valve moves towards a closed configuration in response to fluid flowin a second, opposite direction such as the inhalation direction.

With reference to FIGS. 5A-6B, the flow control device 110 extendsgenerally along a central axis 605 (shown in FIGS. 5B and 6B). The flowcontrol device 110 includes a main body that defines an interior lumen610 through which fluid can flow along a flow path. The dimensions ofthe flow control device 110 can vary based upon the bronchial passagewayin which the flow control device 110 is configured to be implanted. Thevalve does not have to be precisely sized for the bronchial passagewayit is to be placed within. Generally, the diameter D (shown in FIG. 6A)of the flow control device 110 in the uncompressed state is larger thanthe inner diameter of the bronchial passageway in which the flow controldevice 110 will be placed. This will permit the flow control device 110to be compressed prior to insertion in the bronchial passageway and thenexpand upon insertion in the bronchial passageway, which will providefor a secure fit between the flow control device 110 and the bronchialpassageway.

The flow of fluid through the interior lumen 610 is controlled by avalve 612 that is disposed at a location along the interior lumen suchthat fluid must flow through the valve 612 in order to flow through theinterior lumen 610. It should be appreciated that the valve 612 could bepositioned at various locations along the interior lumen 610. The valve612 can be made of a biocompatible material, such as a biocompatiblepolymer, such as silicone. As discussed in more detail below, theconfiguration of the valve 612 can vary based on a variety of factors,such as the desired cracking pressure of the valve 612.

The valve 612 can be configured to permit fluid to flow in onlyone-direction through the interior lumen 610, to permit regulated flowin two-directions through the interior lumen 610, or to prevent fluidflow in either direction.

With reference still to FIGS. 5A-6B, the flow control device 110includes a seal member 615 that provides a seal with the internal wallsof a body passageway when the flow control device is implanted into thebody passageway. The seal member 615 is manufactured of a deformablematerial, such as silicone or a deformable elastomer. The flow controldevice 110 also includes an anchor member or frame 625 that functions toanchor the flow control device 110 within a body passageway.

As shown in FIGS. 5A-6B, the seal member 615 can includes a series ofradially-extending, circular flanges 620 that surround the outercircumference of the flow control device 110. The configuration of theflanges can vary. For example, as shown in FIG. 6B, the radial length ofeach flange 620 can vary. It should be appreciated that the radiallength could be equal for all of the flanges 620 or that the radiallength of each flange could vary in some other manner. In addition, theflanges 620 can be oriented at a variety of angles relative to thelongitudinal axis 605 of the flow control device.

As mentioned, the anchor member 625 functions to anchor the flow controldevice 110 in place when the flow control device is implanted within abody passageway, such as within a bronchial passageway. The anchormember 625 has a structure that can contract and expand in size (in aradial direction and/or in a longitudinal direction) so that the anchormember can expand to grip the interior walls of a body passageway inwhich the flow control device is positioned. In one embodiment, as shownin FIGS. 5A-6B, the anchor member 625 comprises an annular frame thatsurrounds the flow control device 110.

The frame 625 can be formed from a super-elastic material, such asNickel Titanium (also known as Nitinol), such as by cutting the frameout of a tube of Nitinol or by forming the frame out of Nitinol wire.The super-elastic properties of Nitinol can result in the frame exertinga radial force against the interior walls of a bronchial passagewaysufficient to anchor the flow control device 110 in place.

It should be appreciated that the configurations, including the sizesand shapes, of the frame 625 and the seal member 615 can vary from thoseshown in the figures. The seal 615 and/or the frame 625 can contract orexpand in size, particularly in a radial direction. The default state isan expanded size, such that the flow control device 110 will have amaximum diameter (which is defined by either the seal 615 or the frame625) when the flow control device 110 is in the default state. The flowcontrol device 110 can be radially contracted in size during insertioninto a bronchial passageway, so that once the flow control device 110 isinserted into the passageway, it expands within the passageway.

At least a portion of the valve 612 is optionally surrounded by a rigidor semirigid valve protector member 637 (shown in FIGS. 5B and 6B),which is a tubular member or annular wall that is contained inside theseal member 615. In another embodiment, the valve protector can comprisea coil of wire or a ring of wire that provides some level of structuralsupport to the flow control device. The valve protector 637 can beconcentrically located within the seal member 615. Alternately, thevalve 612 can be completely molded within the seal member 615 such thatthe material of the seal member 615 completely surrounds the valveprotector. The valve protector has sufficient rigidity to maintain theshape of the valve member against compression.

In one embodiment, the valve protector member 637 has two or morewindows 639 comprising holes that extend through the valve protectormember, as shown in FIG. 6B. The windows 639 can provide a locationwhere a removal device, such as graspers or forceps, can be inserted inorder to facilitate removal of the flow control device 110 from abronchial passageway.

As mentioned, the structural configuration of the flow control devicecan vary. For example, FIG. 7 shows a perspective view of anotherembodiment of a flow control device 110 that includes a frame 625, avalve 612 mounted in the frame 625, and a membrane 627. The frame 625and the membrane 627 can collectively or individually seal with aninternal wall of a bronchial passageway.

The device 110 in FIG. 7 includes an elastically expandable frame 625that is covered with an elastomeric membrane 627. In one embodiment, thedevice has an expanded frame laser-cut from nitinol tubing that has beenexpanded and heat treated to set it in the shape shown. The frame 625 isdipped in a silicone dispersion so that all outer surfaces are coveredin a thin silicone membrane.

When the device is compressed into a delivery catheter, it may bedelivered through the trachea, using any of a number of well-knowndelivery methods, to the target bronchial lumen, and released from thecatheter. Once released, the device expands and grips the walls of thebronchial lumen, and due to the silicone membrane, blocks fluid (gas andliquid) flow through the lumen in both the inhalation and exhalationdirections. The frame 625 can have points or prongs on the distal end toprevent migration of the device in the distal or inhalation direction.

Of course, the frame may be made of other materials and take othershapes, may be deformable or heat expandable rather than springresilient, and the membrane may be formed from other materials (such asurethane) and may be manufactured using methods other than dipping. Thisparticular device is compact enough to fit into a delivery catheter thatcan fit through the working channel of a bronchoscope that has aninternal diameter of 2.2 mm, however it may be delivered using othermethods.

As discussed above, exemplary implantable one-way valve flow controldevices are shown in FIG. 5A-7. A valve of a flow control deviceincludes regions (referred to herein as coaptation regions) that contactone another to block flow through the valve, and separate from oneanother to allow flow through the valve. The coaptation regions cancontact one another along their entire length or area such that there isno gap between therebetween and the valve is completely closed.

The valve coaptation regions may be in full contact with one another ina default state, such as when there is no pressure differential acrossthe valve. That is, the coaptation regions are in contact with oneanother such that there is no opening for fluid to flow through. Asmentioned, the default state is the state of the valve when exposed tono fluid flow and, therefore, no pressure differential across the valve.When a valve is “closed” the valve coaptation regions contact oneanother so as to block flow through the valve when there is no pressuredifferential across the valve.

The valve member 612 can be any type of fluid valve, and preferably is avalve that enables the cracking pressures described herein. The valvemember 612 can have a smaller diameter than the frame 625 so thatcompression or deformation of the frame 625 in both a radial and axialdirection will have little or no impact on the structure of the valvemember 612. In the embodiment shown in FIGS. 5-7, the valve member 612comprises a duckbill valve that includes two flaps 631 (shown in FIGS.5B and 6B) that are oriented at an angle with respect to one another andthat can open and close with respect to one another so as to form anopening at a lip 801 (FIG. 6B) where the flaps 631 touch one another.The duckbill valve allows fluid flow in a first direction and preventsfluid flow in a second direction that is opposed to the first direction.For example, FIG. 8A shows a schematic side-view of a duckbill valve ina closed state, wherein the flaps 631 touch one another at the lip 801.In the closed state, the duckbill valve prevents fluid flow in a firstdirection, which is represented by the arrow A in FIG. 8A. However, whenexposed to fluid flow with sufficient pressure in a second direction(represented by arrow B in FIG. 8B) that is opposed to the firstdirection, the flaps 631 separate from one another to form an openingbetween the flaps 631 that permits flow in the second direction, asshown in FIG. 8B.

The cracking pressure is defined as the minimum fluid pressure necessaryto open the one-way valve member in a certain direction, such as in thedistal-to-proximal direction. Given that the valve member of the flowcontrol device 110 will be implanted in a bronchial lumen of the humanlung, the flow control device 110 will likely be coated with mucus andfluid at all times. For this reason, the cracking pressure of the valveis desirably tested in a wet condition that simulates the conditions ofa bronchial lumen. A representative way of testing the valve member isto use a small amount of a water based lubricant to coat the valvemouth. The testing procedure for a duckbill valve is as follows: 1.Manually open the mouth of the valve member, such as by pinching thesides of the valve together, and place a drop of a dilute water basedlubricant between the lips of the valve. 2. Wipe excess lubricant off ofthe valve, and force 1 cubic centimeter of air through the valve in theforward direction to push out any excess lubricant from the inside ofthe valve. 3. Connect the distal side of the valve to an air pressuresource, and slowly raise the pressure. The pressure is increased from astarting pressure of 0 inches H₂O up to a maximum of 10 inches H₂O overa period of time (such as 3 seconds), and the peak pressure is recorded.This peak pressure represents the cracking pressure of the valve.

The cracking pressure of the valve member can vary based on variousphysiological conditions. For example, the cracking pressure could beset relative to a coughing pressure, a forced expiration pressure, or anormal respiration pressure. For example, the cracking pressure could beset so that it is higher than normal respiration pressure and lower thana coughing pressure (approximately 25 inches H₂O). In this regard, thenormal or coughing respiration pressure can be determined based on aparticular patient, or it could be determined based on average normal orcoughing respiration pressures. In one embodiment, the cracking pressureof the valve member is in the range of approximately 5-25 inches H₂O. Inanother embodiment, the cracking pressure of the valve is in the rangeof approximately 7-9 inches H₂O. In yet another embodiment, the crackingpressure of the valve is in the range of approximately 11-24 inches H₂O.The cracking pressure of the valve may be set also be set above 25inches H₂O. In an embodiment, the cracking pressure of the valve is inthe range of approximately 26-120 inches H₂O. The cracking pressure ofthe valve may also be set above 120 inches H₂O. In an embodiment thecracking pressure of the valve is in the range of approximately 121-160inches H₂O. The cracking pressure of the valve may also be set above 160inches H₂O.

It may be desirable to have a valve with a cracking pressure abovenormal breathing pressures in order to reduce the risk of the targetedlung region collapsing too quickly. Thus, the cracking pressure may beset such that the valve will not open with an exhale but will open witha cough or forced exhalation. Such a valve will act like a plug duringnormal breathing but will allow mucus to pass during a cough or forcedexhalation.

An example of a valve with a cracking pressure above normal breathingpressures is shown in FIG. 9. The valve 912 comprises a duckbill valvethat includes two opposed, inclined walls or flaps 931 that are orientedat an angle 913 with respect to one another and lips 910 configured tobe parallel with respect to one another in the closed configuration. Theflaps 931 can open and close with respect to one another so as to forman opening between the lips 910. The relative positions of the lips 910determines the size of the opening in the valve 912. When the lips 910are in full contact with one another, there is no opening between thecoaptation regions. In an embodiment, the inclined walls or flaps 931are oriented at an angle relative to the longitudinal axis 905 of thevalve while in the closed configuration. The lips may be configured tobe parallel with the longitudinal axis 905 of the valve while in theclosed configuration.

Various characteristics of the valve 912 may be varied to increase (ordecrease) the cracking pressure of the valve 912. For example, thesmaller the duckbill valve, the higher the cracking pressure that isgenerally required to open the valve. In addition, increasing thethickness 932 of a wall of the valve 912 will increase the crackingpressure. A longer parallel lip length 911 will also increase thecracking pressure of the valve 912. Increasing the angle 913 between theinclined walls or flaps 931 will increase the cracking pressure of thevalve 912. In an embodiment, the angle 913 between the inclined walls orflaps 931 is in the range of approximately 70 to 110 degrees. Thecracking pressure is also increased by orienting the valve 912 moreorthogonal to the direction of flow. In an embodiment the valve 912 isoriented at an angle with respect to the direction of air flow throughthe bronchial passageway. Additionally, the cracking pressure may beincreased by narrowing the opening slit cut between the parallel lips910.

FIGS. 10A-12E show various embodiments of valves with cracking pressuresabove normal breathing. The valves 1012, 1112, 1212 comprise inclinedwalls or flaps 1031, 1131, 1231 that are oriented at an angle withrespect to one another and lips 1010, 1110, 1210 configured to beparallel with respect to one another in the closed configuration. Theflaps 1031, 1131, 1231 can open and close with respect to one another soas to form an opening between the lips 1010, 1110, 1210. The relativepositions of the lips 1010, 1110, 1210 determines the size of theopening in the valve 1012, 1112, 1212. When the lips 1010, 1110, 1210are in full contact with one another, there is no opening between thecoaptation regions. In some embodiments a length of parallel andcontacted lips 1010, 1110, 1210 extending longitudinally beyond theinclined flaps 1031, 1131, 1231 is at least 30% as long as a length ofthe inclined flaps 1031, 1131, 1231. In other embodiments a length ofparallel and contacted lips 1010, 1110, 1210 extending longitudinallybeyond the inclined flaps 1031, 1131, 1231 is at least 40% or 50% aslong as a length of the inclined flaps 1031, 1131, 1231.

While the above is a complete description of the preferred embodimentsof the invention, various alternatives, modifications, and equivalentsmay be used. Therefore, the above description should not be taken aslimiting the scope of the invention which is defined by the appendedclaims.

What is claimed is:
 1. A flow control device suitable for implanting ina bronchial passageway, comprising: a valve element comprising a firstlip and a second lip, wherein the first and second lips are configuredto transition the valve element between a closed configuration thatblocks air flow in the inspiratory direction and an open configurationthat permits air flow in an expiratory direction; wherein the first andsecond lips are configured to be in the closed configuration whenexposed to no air flow, air flow in the inspiratory direction, and airflow in the expiratory direction at normal breathing pressures, andwherein the first and second lips are configured to be in the openconfiguration when exposed to air flow in the expiratory direction inthe range of 12-24 inches H₂O.
 2. The flow control device of claim 1,wherein the first and second lips are configured to be parallel withrespect to one another and a longitudinal axis of the valve while in theclosed configuration; and wherein the valve element further comprisestwo opposed inclined flaps leading to the first and second lips, whereinthe two inclined flaps are oriented at an angle with respect to oneanother.
 3. The flow control device of claim 2, wherein the first andsecond lips are configured to extend longitudinally in contact with oneanother beyond the two inclined flaps while in the closed configuration4. The flow control device of claim 3, wherein a length of the paralleland contacted first and second lips extending longitudinally beyond thetwo inclined flaps and the angle of the inclined flaps with respect toone another are configured such that the valve element is in the closedconfiguration when exposed to no air flow, air flow in the inspiratorydirection, and air flow in the expiratory direction at normal breathingpressures, and such that the valve element is in the open configurationwhen exposed to air flow in the expiratory direction in the range of12-24 inches H₂O.
 5. The flow control device of claim 3, wherein thelength of the parallel and contacted first and second lips extendinglongitudinally beyond the two inclined flaps is at least 30% as long asa length of the inclined flaps.
 6. The flow control device of claim 2,wherein the two inclined flaps are oriented at an angle relative to alongitudinal axis of the valve while in the closed configuration.
 7. Theflow control device of claim 1, wherein the angle is in the range of 70to 110 degrees.
 8. A flow control device suitable for implanting in abronchial passageway, comprising: a valve comprising coaptation regionscomprising two opposed inclined flaps and two parallel lips connected tothe inclined flaps, wherein the coaptation regions are configured totransition the valve element between a closed configuration that blocksair flow in the inspiratory direction and an open configuration thatpermits air flow in an expiratory direction; wherein the coaptationregions are configured to be in the closed configuration when exposed tono air flow, air flow in the inspiratory direction, and air flow in theexpiratory direction at normal breathing pressures, and wherein thecoaptation regions are configured to be in the open configuration whenexposed to air flow in the expiratory direction in the range of 12-24inches H₂O.
 9. The flow control device of claim 8, wherein the twoopposed inclined flaps are configured to be oriented at an angle withrespect to one another in the closed configuration and the two parallellips are configured to be parallel with respect to one another and alongitudinal axis of the valve in the closed configuration.
 10. The flowcontrol device of claim 9, wherein the two parallel lips are configuredto extend longitudinally in contact with one another beyond the twoinclined flaps while in the closed configuration
 11. The flow controldevice of claim 10, wherein a length of the parallel and contactedparallel lips extending longitudinally beyond the two inclined flaps andthe angle of the inclined flaps with respect to one another areconfigured such that the coaptation regions are in the closedconfiguration when exposed to no air flow, air flow in the inspiratorydirection, and air flow in the expiratory direction at normal breathingpressures, and such that the coaptation regions are in the openconfiguration when exposed to air flow in the expiratory direction inthe range of 12-24 inches H₂O.
 12. The flow control device of claim 10,wherein the length of the parallel and contacted parallel lips extendinglongitudinally beyond the two inclined flaps is at least 30% as long asa length of the inclined flaps.
 13. The flow control device of claim 9,wherein the two opposed inclined flaps are configured to be oriented atan angle with respect to a longitudinal axis of the valve in the closedconfiguration.
 14. The flow control device of claim 9, wherein the valveis configured to be oriented at an angle with respect to a direction ofair flow through the bronchial passageway.
 15. A flow control devicesuitable for implanting in a bronchial passageway, comprising: a valveelement comprising a first lip and a second lip, wherein the first andsecond lips are configured to transition the valve element between aclosed configuration that blocks air flow in the inspiratory directionand an open configuration that permits air flow in an expiratorydirection; wherein the first and second lips are configured to be in theclosed configuration when exposed to no air flow, air flow in theinspiratory direction, and air flow in the expiratory direction atnormal breathing pressures, and wherein the first and second lips areconfigured to be in the open configuration when exposed to air flow inthe expiratory direction in the range of 121-160 inches H₂O.
 16. Theflow control device of claim 15, wherein the first and second lips areconfigured to be parallel with respect to one another and a longitudinalaxis of the valve while in the closed configuration; and wherein thevalve element further comprises two opposed inclined flaps leading tothe first and second lips, wherein the two inclined flaps are orientedat an angle with respect to one another.
 17. The flow control device ofclaim 16, wherein the first and second lips are configured to extendlongitudinally in contact with one another beyond the two inclined flapswhile in the closed configuration
 18. The flow control device of claim17, wherein a length of the parallel and contacted first and second lipsextending longitudinally beyond the two inclined flaps and the angle ofthe inclined flaps with respect to one another are configured such thatthe valve element is in the closed configuration when exposed to no airflow, air flow in the inspiratory direction, and air flow in theexpiratory direction at normal breathing pressures, and such that thevalve element is in the open configuration when exposed to air flow inthe expiratory direction in the range of 121-160 inches H₂O.
 19. A flowcontrol device suitable for implanting in a bronchial passageway,comprising: a valve comprising coaptation regions comprising two opposedinclined flaps and two parallel lips connected to the inclined flaps,wherein the coaptation regions are configured to transition the valveelement between a closed configuration that blocks air flow in theinspiratory direction and an open configuration that permits air flow inan expiratory direction; wherein the coaptation regions are configuredto be in the closed configuration when exposed to no air flow, air flowin the inspiratory direction, and air flow in the expiratory directionat normal breathing pressures, and wherein the coaptation regions areconfigured to be in the open configuration when exposed to air flow inthe expiratory direction in the range of 121-160 inches H₂O.
 20. Theflow control device of claim 19, wherein the two opposed inclined flapsare configured to be oriented at an angle with respect to one another inthe closed configuration and the two parallel lips are configured to beparallel with respect to one another and a longitudinal axis of thevalve in the closed configuration.
 21. The flow control device of claim20, wherein the two parallel lips are configured to extendlongitudinally in contact with one another beyond the two inclined flapswhile in the closed configuration
 22. The flow control device of claim21, wherein a length of the parallel and contacted parallel lipsextending longitudinally beyond the two inclined flaps and the angle ofthe inclined flaps with respect to one another are configured such thatthe coaptation regions are in the closed configuration when exposed tono air flow, air flow in the inspiratory direction, and air flow in theexpiratory direction at normal breathing pressures, and such that thecoaptation regions are in the open configuration when exposed to airflow in the expiratory direction in the range of 121-160 inches H₂O.